US20040260247A1 - Drive mechanisms suitable for use in drug delivery devices - Google Patents

Abstract

A drive mechanism suitable for use in drug delivery devices is disclosed. The drive mechanism may be used with injector-type drug delivery devices, such as those permitting a user to set the delivery dose. The drive mechanism may include a housing, a dose dial sleeve having a helical thread of a first lead, and a two-part piston rod. The two-part piston rod may include an outer part having a helical thread of a second lead and an inner part having a helical thread of a third lead. In such an embodiment, the first lead of the thread of the dose dial sleeve may be equal to the sum of the second lead of the thread of the outer part of the piston rod and the third lead of the thread of the inner part of the piston rod.

Description

THE TECHNICAL FIELD OF THE INVENTION
• The present invention relates to drive mechanisms suitable for use in drug delivery devices, in particular pen-type injectors, having dosage setting means, enabling the administration of medicinal products from a multidose cartridge. In particular, the present invention relates to such drug delivery devices where a user may set the dose.[0001]
DESCRIPTION OF RELATED ART
• Such drug delivery devices have application where regular injection by persons without formal medical training occurs, i.e., patients. This is increasingly common amongst those having diabetes where self-treatment enables such persons to conduct effective management of their diabetes.[0002]
• These circumstances set a number of requirements for drug delivery devices of this kind. The device must be robust in construction, yet easy to use in terms of the manipulation of the parts, understanding by a user of its operation and the delivery of the required dose of medicament. Dose setting must be easy and unambiguous. In the case of those with diabetes, many users will be physically infirm and may also have impaired vision requiring the drive mechanism to have low dispensing force and an easy to read dose setting display. Where the device is to be disposable rather than reusable, the device should be cheap to manufacture and easy to dispose of (preferably being suitable for recycling). To meet these requirements the number of parts required to assemble the device and the number of material types the device is made from need to be kept to a minimum.[0003]
• User operated drug delivery devices comprising a telescopic piston rod are well known within the medical field.[0004]
• WO 9114467 A1 discloses a dispensing device, comprising a drive mechanism having a telescopic piston rod consisting of a first and a second threaded member having equi-spaced threaded segments with non-threaded segments therebetween. The device further comprises a dose setting sleeve, which surrounds the second threaded member being coupled for rotation and is threadedly engaged with the device shell. The threads of the three said components are of the same lead. The design of this device requires a body length to plunger length ratio of about 1:1 in order to allow dispensing of relatively large doses. However, simple and safe correction of a set overdose remains unresolved without either dispensing the set amount of fluid or dismantling the cartridge.[0005]
• Surprisingly it was found that the drive mechanism according to instant invention provides a valuable technical alternative for the design of a compact drive mechanism, which requires relatively low force to actuate the mechanism, further providing the advantage of safe dose dialling and dispensing. Furthermore, the drive mechanism according to instant invention provides the advantage of intuitive and easy to use correction of a set dose.[0006]
DESCRIPTION OF THE INVENTION
• According to a first aspect of the present invention, a drive mechanism for use in a drug delivery device is provided, comprising[0007]
• a housing;[0008]
• a dose dial sleeve having a helical thread of a first lead; and[0009]
• a two-part piston rod; characterised in that[0010]
• the said piston rod comprising an outer part having an external helical thread of a second lead and an inner part having an external helical thread of a third lead, whereby the first lead of the thread of the dose dial sleeve is equal to the sum of the second lead of the thread of the outer part of the piston rod and the third lead of the thread of the inner part of the piston rod.[0011]
• The term “drug delivery device” according to instant invention shall mean a single-dose or multi-dose, disposable or re-useable device designed to dispense a selected dose of a medicinal product, preferably multiple selected doses, e.g. insulin, growth hormones, low molecular weight heparins, and their analogues and/or derivatives etc. Said device may be of any shape, e.g. compact or pen-type. Dose delivery may be provided through a mechanical (optionally manual) or electrical drive mechanism or stored energy drive mechanism, such as a spring, etc. Dose selection may be provided through a manual mechanism or electronic mechanism. Additionally, said device may contain components designed to monitor physiological properties such as blood glucose levels, etc. Furthermore, the said device may comprise a needle or may be needle-free. In particular, the term “drug delivery device” shall mean a disposable multi-dose pen-type device having mechanical and manual dose delivery and dose selection mechanisms, which is designed for regular use by persons without formal medical training such as patients. Preferably, the drug delivery device is of the injector-type.[0012]
• The term “housing” according to instant invention shall preferably mean any exterior housing (“main housing”, “body”, “shell”) or interior housing (“insert”, “inner body”). The housing may be designed to enable the safe, correct, and comfortable handling of the drug delivery device or any of its mechanism. Usually, it is designed to house, fix, protect, guide, and/or engage with any of the inner components of the drug delivery device (e.g., the drive mechanism, cartridge, plunger, piston rod) by limiting the exposure to contaminants, such as liquid, dust, dirt etc. In general, the housing may be unitary or a multipart component of tubular or non-tubular shape. Usually, the exterior housing serves to house a cartridge from which a number of doses of a medicinal product may by dispensed.[0013]
• In further embodiments of instant invention, the exterior housing, the dose dial sleeve and/or the drive sleeve are provided with one or more maximum dose stops adapted to be abutted by a corresponding radial stop provided on the respective corresponding engaging component.[0014]
• The term “engaged” according to instant invention shall particularly mean the interlocking of two or more components of the drive mechanism/drug delivery device, e.g. a spline or thread connection, preferably the interlocking of helical threads of components (“threadedly engaged”).[0015]
• The term “helical thread” according to instant invention shall preferably mean a full or part thread, e.g., a cylindrical spiral rib/groove, located on the internal and/or external surface of a component of the drug delivery device, having an essentially triangular or square or rounded section designed to allow continuous free rotational and/or axial movement between components. Optionally, said thread may be further designed to prevent rotational or axial movement of certain components in one direction.[0016]
• The term “dose dial sleeve” according to instant invention shall mean an essentially tubular component of essentially circular cross-section having either:[0017]
• a) both an internal and external thread, or[0018]
• b) an internal thread, or[0019]
• c) an external thread.[0020]
• Preferably, the dose dial sleeve according to instant invention comprises a helical thread having a lead, which is similar to, preferably the same as the sum of the leads of the helical threads of the inner and the outer part of the two-part piston rod. In another preferred embodiment of instant invention, the dose dial sleeve is threadedly engaged with the housing, and, in a particular embodiment, the dose dial sleeve comprises a first section of a first diameter and a second section of a second diameter, whereby the outer surface of the first section of the dose dial sleeve is threadedly engaged with the housing.[0021]
• In yet another preferred embodiment the dose dial sleeve is designed to indicate a selected dose of a dispensable product. This may be achieved by use of markings, symbols, numerals, etc., e.g. printed on the external surface of the dose dial sleeve or an odometer, or the like.[0022]
• The term “lead” according to instant invention shall preferably mean the axial distance a nut would advance in one complete revolution; preferably “lead” shall mean the axial distance through which a component having a helical thread, i.e. dose dial sleeve, drive sleeve, piston rod, etc., of the drive mechanism travels during one rotation. Therefore lead is a function of the pitch of the thread of the relevant component.[0023]
• The term “pitch” according to instant invention shall preferably mean the distance between consecutive contours on a helical thread, measured parallel to the axis of the helical thread.[0024]
• Optionally, the drive mechanism of instant invention further comprises a drive sleeve, whereby the term “drive sleeve” according to instant invention shall mean any essentially tubular component of essentially circular cross-section and which is engaged with the dose dial sleeve, and is even more preferred further engaged with the piston rod.[0025]
• In a particular embodiment of instant invention, the drive sleeve comprises a helical thread along an internal surface extending from a first end of the drive sleeve towards an internal land, the land being further provided with a radially inwardly directed flange.[0026]
• The term “releasibly connected” according to instant invention shall preferably mean that two components of instant mechanism or device are reversibly joined to each other, which allows coupling and decoupling, e.g. by means of a clutch.[0027]
• The term “piston rod” according to instant invention shall mean any two-part component adapted to operate through/within the housing, designed to translate axial movement through/within the drug delivery device, preferably from the drive sleeve to the piston, for the purpose of discharging/dispensing an injectable product. The “two-part piston rod” of instant invention shall further mean a component having a circular or non-circular cross-section. It may be made of any suitable material known by a person skilled in the art.[0028]
• The term “two-part piston rod” according to instant invention comprises an outer and an inner component (“outer part” and “inner part”) and at least two helical threads, preferably an external helical thread on the outer part and an external helical thread on the inner part, In other preferred embodiments of instant invention, the sum of the leads of the said threads of the inner and outer part of the “two-part piston rod” is equal to the lead of the thread of the dose dial sleeve. The meaning of the term “is equal to” according to instant invention shall encompass similar, essentially the same, or the same values of the leads of the said threads, whereby it is essentially provided that the function of the threaded engagement of the above mentioned threaded components is maintained. Optionally, the leads of the said threads of the inner and outer part of the said piston rod are of opposite dispositions. One of the said threads may be designed to engage with the drive sleeve. In still another preferred embodiment of instant invention the inner and the outer part of the said piston rod are adapted for longitudinal displacement but are restricted for rotation with respect to each another.[0029]
• In another preferred embodiment of the invention, the outer part of the said piston rod is adapted for longitudinal displacement only with respect to the housing, e.g., by a ratchet means. In one particular embodiment of instant invention, the said ratchet means is in the form of barbs or tangs extending from the housing.[0030]
• The term “first end” according to instant invention shall mean the proximal end. The proximal end of the device or a component of the device shall mean the end, which is closest to the dispensing end of the device.[0031]
• The term “second end” according to instant invention shall mean the distal end. The distal end of the device or a component of the device shall mean the end, which is furthest away from the dispensing end of the device.[0032]
• Optionally, the drive mechanism of instant invention further comprises a clutch means, whereby the term “clutch means” according to instant invention shall mean any clutch, which releasibly connects the dose dial sleeve and the inner part of the said piston rod and which is designed to allow rotation of the dose dial sleeve and the inner part of the said piston rod with respect to the housing when the dose dial sleeve and the inner part of the said piston rod are coupled. Particularly, the clutch means couples the inner part of the piston rod to the dose dial sleeve thereby preventing rotation between the inner part of the piston rod and the dose dial sleeve when engaged. Preferably, the clutch means is located between the dose dial sleeve and the said piston rod, in particular, the inner part of the said piston rod.[0033]
• Accordingly, the term clutch means is any clutch engaging for the purpose of reversibly locking two components in rotation, e.g., by use of axial forces to engage a set of face teeth (saw teeth, dog teeth, crown teeth) or any other suitable frictional faces.[0034]
• In one particular embodiment of instant invention, the clutch means comprises a plurality of radially extending longitudinally directed teeth provided respectively on the dose dial sleeve and a disc connected to the inner part of the piston rod.[0035]
• In still another embodiment of instant invention, the drive mechanism comprises a clicker means, e.g., disposed between the clutch means and the dose dial sleeve, between the inner and the outer part of the piston rod, or wherever applicable.[0036]
• Optionally, the clicker means comprising an inserted component having an upper part and a lower part depending therefrom, the upper part of the inserted component is provided on an internal surface with a plurality of circumferentially spaced longitudinally extending teeth, the lower part of the inserted component comprising a flexible toothed member being disposed in alignment with a plurality of circumferentially disposed longitudinally directed teeth provided on an inner surface of the dose dial sleeve, and the inner surface of the upper part of the inserted component having a plurality of circumferentially disposed longitudinally extending teeth being disposed in alignment with a flexible toothed member provided on the clutch means such that relative rotation between the dose dial sleeve and the clutch means causes one of the flexible toothed members to ride over corresponding longitudinally directed teeth to produce a series of clicks.[0037]
• A second aspect of instant invention provides an assembly for use in a drug delivery device comprising the drive mechanism according to instant invention.[0038]
• A third aspect of the present invention provides a drug delivery device comprising the drive mechanism or the assembly according to instant invention.[0039]
• A fourth aspect of the present invention provides a method of assembling a drug delivery device comprising the step of providing a drive mechanism or an assembly according to instant invention.[0040]
• A fifth aspect of instant invention is the use of a drug delivery device according to instant invention for dispensing a medicinal product preferably dispensing a pharmaceutical formulation (e.g. solution, suspension etc.) comprising an active compound selected from the group consisting of insulin, growth hormone, low molecular weight heparin, their analogues, and their derivatives.[0041]
BRIEF DESCRIPTION OF THE DRAWINGS
• Without any limitation, the instant invention will be explained in greater detail below in connection with a preferred embodiment and with reference to the drawings in which:[0042]
• FIG. 1 shows a sectional view of an embodiment of the drug delivery device according to the present invention in a first, cartridge full, position;[0043]
• FIG. 2 shows a sectional view of the drug delivery device of FIG. 1 in a second, maximum first dose dialed, position;[0044]
• FIG. 3 shows a sectional view of the drug delivery device of FIG. 1 in a third, maximum first dose dispensed, position;[0045]
• FIG. 4 shows a sectional view of the drug delivery device of FIG. 1 in a fourth, final dose dialed, position;[0046]
• FIG. 5 shows a sectional view of the drug delivery device of FIG. 1 in a fifth, final dose dispensed, position.[0047]
• Referring first to FIG. 1 there is seen a drug delivery device in accordance with the present invention. The device comprises a[0048]housing2 within which is located acartridge4 containing a medicinal product, means for selecting or setting of the dose of medicinal product to be expelled and means for expelling the selected dose of medicinal product Thehousing2 is generally cylindrical in shape and is divided into two compartments by aweb6 to be described in more detail below. Thecartridge4 is located within a first end of thehousing2 while the dose setting means and the means for expelling the selected dose of medicinal product are located within a second end of thehousing2.
• The[0049]cartridge4 may be secured in position in the first end of thehousing2 by any suitable means. In the illustrated embodiment, acartridge retainer12 is secured, by any suitable means, to a first side of the web to retain the cartridge in position. A needle unit (not shown) may be secured to a first end of thecartridge retainer12. Thecartridge4 further comprises adisplaceable piston10. Advancing thepiston10 towards the first end of thecartridge4 causes the medicinal product to be expelled from thecartridge4 through the needle unit. A cap may be provided to cover the needle unit when the device is not in use.
• The[0050]web6 dividing thehousing2 extends radially inwards from the cylindrical housing to define anopening8. Apiston rod14 extends through theopening8 in theweb6. Thepiston rod14 comprises a firstinner part16 and a secondouter part18. Theinner part16 and theouter part18 of the piston rod are keyed or ratcheted by a one-way ratchet to one another for longitudinal displacement therebetween such that rotation between the inner and outer parts of thepiston rod14 is restrained in a first direction. In the illustrated embodiment, theinner part16 is keyed to theouter part18 by at least one radially extendingflexible barb17 extending from theinner part16 that runs in longitudinally extendinggrooves19 on an inner surface of theouter part18 of thepiston rod14. In the illustrated embodiment, two diametrically opposedflexible barbs17 are used, only one of which may be seen in each view, the other being hidden.
• The first[0051]inner part16 of thepiston rod14 is provided along a second end with a threadedportion22. The secondouter part18 of thepiston rod14 is provided along a second end with a helical rib (thread)24 on an outer surface thereof.
• A[0052]ratchet20 is provided in the form of a number of barbs or tangs extending from the housing. Theratchet20 prevents relative rotation between theouter part18 of thepiston rod14 and thehousing2. Theratchet20 also prevents theouter part18 of thepiston rod14 from retracting counterwise back into themain housing4, that is away from thecartridge piston10.
• The dose setting means and the means for expelling the selected dose of medicinal product will now be described in more detail.[0053]
• A[0054]drive sleeve30 is located at a second end of thepiston rod14. Thedrive sleeve30 is cylindrical. A helical groove (thread)32 extends along an internal surface of thedrive sleeve30 from a first end of thedrive sleeve30 towards aninternal land34. Theland34 is further provided with asecond thread36 for engagement with the threadedportion22 on theinner part16 of thepiston rod14.
• The[0055]helical groove32 and thehelical rib24 engage to permit relative rotation between theouter part18 of thepiston rod14 and thedrive sleeve30. Thesecond thread36 runs in the threadedportion22 of theinner part16 of thepiston rod14 to permit relative rotation between thedrive sleeve30 and theinner part16 of thepiston rod14.
• The[0056]helical rib24 andsecond thread36 are opposite handed.
• A[0057]dose dial sleeve40 is of generally cylindrical form and comprises a first section of first diameter and a second section of second diameter. The first section is disposed between thedrive sleeve30 and thehousing2. An outer surface of the first section and an inner surface of thehousing2 are provided with interengaging features to provide a helical thread41 between thehousing2 and thedose dial sleeve40. This enables thedose dial sleeve40 to rotate about and along thehousing2. The outer surface of thedose dial sleeve40 is provided with numerals or other indications (not shown) of the possible doses to be dialled. The housing is provided with a window (not shown) through which a numeral or other indication representative of the users chosen dosage is displayed.
• The[0058]dose dial sleeve40 and thedrive sleeve30 are splined together. The inner surface of thedose dial sleeve40 and the outer surface of thedrive sleeve30 are keyed together to permit only longitudinal displacement therebetween.
• The second section of the[0059]dose dial sleeve40 is of the same outer diameter as thehousing2. Within thedose dial sleeve40 there is ashoulder42 between the first section of thedose dial sleeve40 and the second section of thedose dial sleeve40. An internal surface of theshoulder42 is provided with a plurality of radially extending longitudinally directed teeth. An internal surface of the second section of thedose dial sleeve40 is provided with a plurality of circumferentially spaced longitudinally extendingsaw teeth54. Each of the saw teeth has a radially directed surface and an inclined surface.
• The second section of the[0060]dose dial sleeve40 comprises a first recessed region in which is retained a clutch48 and a further region in which abutton50 is retained. Thebutton50 is free to rotate within the second section of thedose dial sleeve40 and is axially connected to the clutch48. Thebutton50 is of generally “T” shaped configuration, the stem of which is retained within a peripheral recess provided in the clutch48. The stem of thebutton50 is provided with a peripheral bead that is retained in the peripheral recess, thebutton50 being able freely to rotate with respect to the clutch and thedose dial sleeve40, but being retained axially within the clutch48.
• The clutch includes a disc having a plurality of radially extending longitudinally directed teeth, The clutch[0061]48 is retained on the firstinner part16 of thepiston rod14 such that there is no relative rotation therebetween. When thedose dial sleeve40 and the clutch48 are not forced together the respective teeth will ride over one another. Preferably, the radial separation of the respective teeth corresponds to a unit dosage. The clutch48 is connected to theinner part16 of thepiston rod14 such that relative rotation therebetween is prevented.
• A clicker is also provided between the clutch[0062]48 and the second section of thedose dial sleeve40. In the illustrated embodiment, the second section of thedose dial sleeve40 is provided with an insertedcomponent44 having an upper part and a lower part depending therefrom. The upper part of the insertedcomponent44 is provided on an internal surface with a plurality of circumferentially spaced longitudinally extending saw teeth. Each of the saw teeth has a radially directed surface and an inclined surface. The clutch48 carries a flexibletoothed member52 about an upper region of the clutch48 aligned with the upper part of the insertedcomponent44
• The lower part of the inserted[0063]component44 is in the form of a flexible toothed member normally biased in a radially outward direction. The lower part of the insertedcomponent44 is normally aligned with theteeth54 provided on the internal surface of the second section of thedose dial sleeve40.
• The radial separation of the teeth on each of the[0064]dose dial sleeve40 and the insertedcomponent44 preferably corresponds to a unit dosage.
• Relative rotation between the[0065]dose dial sleeve40 and the clutch48 in a first direction will cause the flexibletoothed member52 to ride over the inclined surfaces of the saw teeth on the insertedcomponent44 to produce a series of clicks. Conversely, relative rotation between thedose dial sleeve40 and the clutch48 in a second direction opposite to the first direction will cause the flexibletoothed member52 to abut the radial surface of one of the saw teeth of the upper part of the inserted component and push the insertedcomponent44 in the second direction. However the lower part of the insertedcomponent44 is then caused to ride over the inclined surfaces of thesaw teeth54 on thedose dial sleeve40 to produce a series of clicks.
• The first direction may be selected to represent an upward or downward dialling of a dose, the second direction the converse dialling condition subject to a suitable arrangement of the flexible members and longitudinally extending teeth.[0066]
• In FIG. 1, the device is provided with a[0067]prefilled cartridge4. To operate the device a user must first select a dose. To set a dose the second section of thedose dial sleeve40 is rotated with respect to thehousing2 outward from thehousing2. Since thedrive sleeve30 cannot rotate with respect to thedose dial sleeve40, this is rotated out from an initial position by an amount corresponding to the desired dosage. Thedrive sleeve30 is thus rotated about thehelical rib24 of theouter part18 of the piston rod. Thesecond thread36 of thedrive sleeve30 thus also runs in the threadedportion22 of theinner part16 of thepiston rod14 drawing theinner part16 of thepiston rod14 from theouter part18 by a distance a function of the dosage chosen by a user. When a dose is dialled, thedrive sleeve30 descends on aninner part16 of the piston rod a distance equal to the distance required to displace thecartridge piston10 to expel the selected dose of medical product.
• In the illustrated embodiment, on dialling up of a dose the relative rotation between the[0068]dose dial sleeve40 and the clutch48 (fixed rotationally with respect to theinner part16 of the piston rod14) causes the flexible toothed member of the insertedcomponent44 to ride over theteeth54 on thedose dial sleeve40 to create a series of clicks. This is an audible confirmation of the dose being dialled. On dialling down, the insertedcomponent44 is locked to the dose dial, and theflexible member52 acts on the teeth of insertedcomponent44. In this way an audible confirmation of the dialling action of a user is produced.
• The user may rotate the[0069]dose dial sleeve40 to increase or decrease the amount of the dosage selected to be delivered. Conveniently, the first section of thedose dial sleeve40 is provided with a marked scale, which together with associated features of the housing, enable a user to determine the amount of the dosage selected to be delivered. The associated features of thehousing2 may include a window formed in thehousing2 or a marking on thehousing2 for alignment with the marked scale.
• Once a desired dose has been set (as shown in FIG. 2), to deliver the dose the user depresses the[0070]button50 to urge thebutton50 and associated clutch48 towards the first end of thehousing2. When thebutton50 is depressed the clutch48 is driven into the second section of thedose dial sleeve40 to prevent relative rotation between thedose dial sleeve40 and theinner part16 of thepiston rod14. Thebutton50 may still rotate with respect to the dose dial sleeve and thedrive sleeve30. Further longitudinal movement of thebutton50 causes the dose dial sleeve40 (together with the drive sleeve30) to rotate towards the first end of the device. As thedose dial sleeve40 travels into thehousing2, rotation of the drive sleeve30 (keyed to the dose dial sleeve40) forces theouter part18 of thepiston rod14 to move axially with respect to thehousing2.
• Rotation of the[0071]inner part16 of thepiston rod14 within theouter part18 of thepiston rod14 as the button is advanced towards the first end of thehousing2 causes thebarb17 to run across thegrooves19 to provide tactile and audible feedback as each unit of medicinal product is dispensed. It may be seen that preferably, the angular spacing of thegrooves19 preferably corresponds to a unit dose.
• The[0072]outer part18 of thepiston rod14 continues to advance until thedose dial sleeve40 has returned to the initial position in relation to the housing and the drive sleeve has returned to its initial position in relation to theouter part18 of the piston rod14 (FIG. 3).
• Further dosages may be delivered as required. FIG. 4 shows an example of a subsequently selected dosage. It will be noted that the[0073]drive sleeve30 has advanced further along the threadedportion22 of theinner part16 of thepiston rod14. The position of thedrive sleeve30 along the threadedportion22 corresponds to the amount of medicinal product remaining in thecartridge4, such that when thedrive sleeve30 reaches the end of the threadedportion22 and can rotate no further, this corresponds to no medicinal product remaining in thecartridge4. It will be seen that if a user seeks to select a quantity of medical product greater than that remaining in thecartridge4, this cannot be done since when thedrive sleeve30 stops rotating this prevents further rotation of thedose dial sleeve40 and setting of a larger dose.
• FIG. 5 shows a device according to the present invention in which the entire medical product within the[0074]cartridge4 has been expelled.

Claims (19)

1. A drive mechanism for use in a drug delivery device comprising:

a housing;

a dose dial sleeve having a helical thread of a first lead; and

a two-part piston rod; characterised in that the two-part piston rod comprises an outer part having a helical thread of a second lead and an inner part having a helical thread of a third lead, whereby the first lead of the thread of the dose dial sleeve is equal to the sum of the second lead of the thread of the outer part of the piston rod and the third lead of the thread of the inner part of the piston rod.

2. An assembly for use in a drug delivery device comprising the drive mechanism ofclaim 1.

3. A drug delivery device comprising the drive mechanism ofclaim 1.

4. The drug delivery device according toclaim 3, wherein the delivery device is a pen-type device.

5. The drug delivery device according toclaim 3, wherein the delivery device is an injector-type device.

6. The drug delivery device according toclaim 3, wherein the device further comprises a needle.

7. The drug delivery device according toclaim 3, wherein the device is a needle-free device.

8. Canceled

9. The method ofclaim 11, wherein dispensing a medicinal product includes dispensing a pharmaceutical formulation comprising an active compound selected from the group consisting of insulin, growth hormone, low molecular weight heparin, analogues thereof, and derivatives thereof.

10. The method of manufacturing or assembling a drug delivery device, comprising the step of providing a drive mechanism according toclaim 1.

11. A method of delivering a drug, comprising:

providing the device ofclaim 3,

dispensing a medicinal product with the device.

12. A drug delivery device comprising the assembly ofclaim 2.

13. The drug delivery device ofclaim 12, wherein the device is a pen-type device.

14. The drug delivery device ofclaim 12, wherein the device is an injector-type device.

15. The drug delivery device ofclaim 12, further comprising a needle.

16. The drug delivery device ofclaim 12, wherein the device is a needle-free device.

17. A method of delivering a drug, comprising:

providing the device ofclaim 12,

dispensing a medicinal product with the device.

18. The method ofclaim 17, wherein dispensing a medicinal product includes dispensing a pharmaceutical formulation from the device, wherein the pharmaceutical formulation comprises an active compound selected from the group consisting of insulin, growth hormone, low molecular weight heparin, analogues thereof, and derivatives thereof.

19. A method of manufacturing or assembling a drug delivery device, comprising providing the assembly ofclaim 2.

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